Automated blood sampling (“ABS”) is a method of automatically collecting serial blood or other fluid samples from a patient for diagnostic or research purposes. ABS reduces the trauma associated with multiple “sticks” (insertion of a needle into a vein or artery) during the repeated blood sampling that is necessary to monitor disposition of drug treatments. This may have particular relevance in sampling blood or other fluids from very young infants, such as those in neonatal or pediatric intensive care, who may have little blood to spare.
ABS has benefits in research, such as during Phase 1 and Phase 2 Clinical Trials (in association with electrocardiography, blood pressure recording, and body temperature monitoring). Automating the process of blood or fluid sampling potentially allows sampling to be done with greater temporal accuracy (i.e. the collection of samples at a specific time), allows for the use of less human personnel, and reduces the amount of fluid wasted compared to manual methods of acquiring the same samples and data. Automated blood sampling may also reduce the risk of infections, including nosocomial infections.
ABS units may also be provided in a portable embodiment. In some embodiments, the ABS unit includes a battery or other portable power source. The use of a portable ABS allows for greater mobility of the patient during sample collection. Patients may be able to go about daily activities, such as eating meals, sending emails, reading a book, and walking to a restroom, while attached to an ABS unit. Greater mobility and fewer sticks may lead to reduced stress. Stress involves the release of various hormones, and such hormones may affect the samples being collected in both human and non-human studies. U.S. Pat. No. 8,052,617 discloses an apparatus and a method for conducting automated blood sampling, the teachings of which are herein incorporated by reference.
Biomedical research techniques, such as infusion, in vivo microdialysis, in vivo ultrafiltration, in vivo electrochemistry, and electrocardiology study the performance of living organs, such as the brain, heart, circulatory system, muscles, etc. These techniques also require connections between one or more external devices and one or more sensors or implants in the body. Examples of devices include syringe pumps, fraction collectors, electrometers, vacuum sources, light sources, and potentiostats. Examples of implants include infusion cannulae, ultrafiltration probes, microdialysis probes, electrodes, and biosensors.
The present disclosure provides an apparatus and method for collecting a fluid sample from a subject for a test. In one exemplary embodiment, the test subject is an adult human. In another exemplary embodiment, the subject is a human child. As used herein, “test” may comprise collection of a fluid sample, as in automated blood sampling, sampling of another body fluid, or parallel acquisition of an electronic signal, such as during blood pressure or electrocardiogram monitoring. The fluid sample collected may be used in medical or clinical analysis of the patient for diagnostic or research purposes. In one embodiment, the sample collection and analysis are provided as a part of neonatal, pediatric or adult intensive care of the patient, including but not limited to military intensive care. In another embodiment, the sample collection and analysis are provided as a part of a personalized medicine regime or treatment. Example of personalized medicine treatment include, but are not limited to, measuring the circulating concentration of an administered drug or tracking the patient's chemical response to a drug. In still another embodiment, the sample collection and analysis are provided as a component of biomedical research. Those of skill in the art will recognize that the sample collection and analysis may also be provided as part of other medical or clinical processes.
In an exemplary embodiment, the disclosure provides a replaceable cartridge for an ABS apparatus. In another exemplary embodiment, a method of collecting a fluid sample from a test subject for a test using an ABS apparatus with a replaceable cartridge is provided.
In one embodiment, a cartridge for a fluid sampling apparatus for collecting a fluid sample from a test subject is provided. In an exemplary embodiment, the cartridge includes a pump, a reservoir fluidly connected to the pump, a first fitting for connecting the cartridge to a tubing sampling fluid from a test subject, a second fitting for connecting the cartridge to a sample collection component, and a third fitting for connecting the cartridge a sterile fluid supply, wherein the pump is configured to move in response to the fluid sampling apparatus and a plurality of valves controlling the flow between the reservoir, pump, and fittings. In another exemplary embodiment, the cartridge is a sterilized, disposable cartridge that can be replaced in the fluid sampling apparatus by a similar cartridge.
In another embodiment, a method for collecting a fluid sample from a test subject is provided. In an exemplary embodiment, the method includes coupling a cartridge to a fluid sampling apparatus, the cartridge comprising a pump, a reservoir, a reservoir fluidly connected to the pump, a first fitting for connecting the cartridge to a tubing sampling fluid from the test subject, a second fitting for connecting the cartridge to a sample collection component, and a third fitting for connecting the cartridge to a sterile fluid supply, wherein the pump is configured to move in response to the fluid sampling apparatus and a plurality of valves control flow between the reservoir, pump, and fittings. The exemplary embodiment also includes connecting the distal end of the tubing into the test subject, opening a first valve and moving the pump to draw sample fluid into the reservoir, opening a second valve and moving the pump to force fluid from the reservoir into the sample collection component, and flushing the fittings with sterile fluid, where the pump and valves are controlled by a controller. In another exemplary embodiment, the cartridge is disposable and can be simply and easily replaced with a sterile, disposable cartridge, reducing labor costs for health care providers.
In one exemplary embodiment, an ABS apparatus capable of receiving a cartridge is incorporated with a portable electric power supply into a wheeled neonatal intensive care unit (NICU) isolette or incubator or an intensive care unit (ICU) bed to enable sampling to continue while a patient is moved between rooms. In another exemplary embodiment, an ABS apparatus capable of receiving a cartridge is incorporated as a part of exercise physiology devices, including but not limited to treadmills and stationary bicycles, for stress tests such as stress electrocardiograms, and evaluation of athletes, patients, or members of the military. In still another exemplary embodiment, an ABS apparatus capable of receiving a cartridge is incorporated into a military long range pallet system used to air transport battle casualties.
In one embodiment, the ABS apparatus is used in a research application to anticipate a decline in patient status by collecting fluid samples and analyzing the samples, such as, but not limited to, determining blood gases, electrolytes, glucose, biomarkers, and drug or metabolite concentrations. In another embodiment, the ABS apparatus is used in a research, clinical, or treatment application to collect fluid samples over time to monitor and track the chemical response to an intervention.
The above mentioned and other features of the invention, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings.